(Order No. 32 of SDA)
The Good Agricultural Practice for Chinese Crude Drugs (Interim) was passed by the State Drug Administration at the administration affairs meeting on March 18 of 2002, is hereby promulgated and shall go into effect as of June 1, 2002.
April 17, 2002
Good Agricultural Practice for Chinese Crude Drugs (Interim)
Chapter I General Provisions
Article 1 The Good Agricultural Practice (GAP) for Chinese Crude Drugs is formulated to regulate the production of Chinese crude drugs, ensure their quality and facilitate the standardization and modernization of traditional Chinese medicines.
Article 2 This GAP provides the basic principles for the production and quality management of Chinese crude drugs and is applicable to producers of Chinese crude drugs (hereinafter referred to as producers) for the entire production process of Chinese crude drugs (from plant or animal origin).
Article 3 Producers should adopt standardized management and quality control to protect resources of natural crude drugs and the ecological environment, and realize sustainable utilization based on the principle of “maximum sustainable yield”.
Chapter II Ecological Environment of Production Site
Article 4 Producers should rationally select their production sites for Chinese crude drugs according to the principle of optimization and local conditions.
Article 5 The environment condition of production sites for Chinese crude drugs should meet the requirements of the related national standards:
“Atmospheric Conditions Standard”, Grade 2 for air quality;
“Soil Quality Standard”, Grade 2 for soil;
“Farm Irrigation Water Standard”, Grade 2 for irrigation;
“Drinking Water Standard” for animal drinking water.
Article 6 Medicinal animal rearing sites should meet the requirements for the ecological environment of the animal population, and appropriate conditions of the animal’s habitat and reproduction.
Chapter III Germ-plasma and Propagation Material
Article 7 Species, subspecies, varieties or cultivars of medicinal plants and animals reared, cultivated or existing in the wild should be clearly identified and recorded in the Chinese adopted name and Latin name.
Article 8 Testing and quarantining procedures should be carried out in the process of production, storage and transportation of seeds, strains and propagation material to ensure their quality, prevent the spread of diseases, pests and weeds, as well as the trade in, and spread of, counterfeit and substandard seeds, strains and propagation materials.
Article 9 The introduction and domestication of animal breeds should be based on their habits. Physical and/or mental injuries to the animals should be avoided in the process of capture and transportation. Introduced breeds should be strictly quarantined, and observed for a specified period of time.
Article 10 The selection or breeding of fine varieties or breeds should be enhanced, their propagation bases should be established, and germ-plasma resources of medicinal plants and animals should be protected.
Chapter IV Management for Cultivation and Rearing
Section 1 Management for Cultivation of Medicinal Plants
Article 11 An appropriate area for cultivation should be determined and standard operating procedures for cultivation should be formulated subject to the growing and developing needs for medicinal plants.
Article 12 Types, period and amount of fertilization should be determined according to the nutritional requirements of the medicinal plants and soil fertility. Organic manures should be the main fertilizing agent, and fertilizers could be applied sparingly in accordance with the growing and developing needs of plants.
Article 13 The use of farmyard manures could be allowed when they are thoroughly composted and meet the sanitary standards. The use of house garbage, industrial wastes, hospital refuse and feces are strictly prohibited.
Article 14 Timely and appropriate irrigation and drainage should be carried out in accordance with the needs of plants in different periods of growth, and the conditions of climate and soil moisture. The soil should be well aerated.
Article 15 Field management should be strengthened in accordance with growing and developing characteristics of medicinal plants and their parts for use, and topping, deflowering, pruning, shading and other measures should be taken timely to adjust the growth and development of plants so as to increase the yield of the crude drugs and maintain the consistency of quality.
Article 16 Integrated pest management should be adopted for the control of diseases and pests. If necessary, minimum effective input of pesticides with high-efficacy, hypo-toxicity and low-residue could be used according to the Regulations for Pesticides Management of the Peoples Republic of China, so as to reduce residues of pesticides, avoid heavy metals contamination and protect the ecological environment.
Section 2 Management for Rearing Medicinal Animals
Article 17 Standard operating procedures and relevant rearing methods should be carried out according to the living environment, dietary needs, behavioral character and adaptability of medicinal animals.
Article 18 Fodder should be formulated and fed timely and in quantity, in accordance with seasonal behaviour, activities day and night, period of growth and physiological character of the animals. Fine fodder, vitamins, minerals and other essential additives should be replenished at appropriate time and with appropriate quantities. Hormones, para-hormones, and other additives, are not allowed to be added. Feeds and additives should not be contaminated.
Article 19 Time and frequency of water supply for medicinal animals should be based on seasons, temperature, ventilation etc. Herbivores should be adequately fed with succulence for water supplement.
Article 20 Sites with appropriate space and security facilities should be established according to the habit and behaviour of medicinal animals.
Article 21 Rearing areas should be kept clean and sanitary.Disinfections practices should be established to disinfect the living places and equipment periodically with appropriate disinfectants. Personnel access to the rearing sites should be controlled.
Article 22 Prevention should be emphasized for the prevention and treatment of epidemic diseases of medicinal animals. Vaccination should be periodically conducted.
Article 23 Rearing areas should be appropriately divided to keep a proper density for medicinal animals that are reared in groups. Sick animals should be timely isolated. The animal(s) with infectious diseases should be culled, and cremated or buried deeply.
Article 24 The composition and structure of the animal population should be determined and adjusted based on a rearing plan and breeding needs.
Article 25 Poisoned and infected medicinal animals are prohibited from processing into Chinese crude drugs.
Chapter V Collection and Primary Processing
Article 26 Collection of wild and semi-wild medicinal plants or animals should conform to the principle of "maximum sustainable yield". Their fostering, rotation and conservation should be planned and carried out to benefit their propagation and renewal of resources.
Article 27 Appropriate collection time (season and years) and methods should be determined in accordance with the quality and yield of the plants or the number of animals bred and with reference to traditional experience, etc.
Article 28 Machines and tools for collection should be kept clean and free of contamination, and stored in a dry place inaccessible for insects, rodents, poultry and livestock.
Article 29 In the course of collection and primary processing, non-medicinal portions and foreign matter should be removed, especially weeds and toxic substances. Damaged and perished parts should be excluded.
Article 30 After being collected, the medicinal parts should be selected, washed, cut or trimmed, etc. Those that need drying should be dried timely by using appropriate methods and techniques, with controlled temperature and humidity. The contamination of Chinese crude drugs should be prevented and degradation of their active constituents should be avoided.
Article 31 Chinese crude drugs to be used fresh may be stored under cool conditions, in sands, in jars, or by biological and other fresh-preserving measures. The use of anti-oxidant agents and preservatives should preferably be avoided. If used, they must conform to national regulatory requirements on food additives.
Article 32 Processing sites should be clean and well ventilated, and fitted with awnings, canopies and devices to prevent entry by insects, rodents, poultry and livestock.
Article 33 Geo-authentic (Di Dao) crude drugs should be processed according to traditional methods. Any change in methods should be based on sufficient experimental data, and should not affect the quality of the Chinese crude drugs.
Chapter VI Packaging, Transportation and Storage
Article 34 Prior to packaging, crude drugs should be checked, and substandard ones and foreign matter should be eliminated. The standard operating procedure for packaging should be followed and a batch packaging record should be documented. The record should include product name, specification, production site, batch number, weight, operator number and packaging date, etc.
Article 35 The packaging materials to be used should be clean, dry, uncontaminated and undamaged, and conform to the quality requirements for crude drugs.
Article 36 On each package of the crude drugs, the product name, specification, production site, batch number, packaging date and the name of producer should be indicated and a sign for qualified products should be marked.
Article 37 Fragile crude drugs should be packaged in hard boxes. Poisonous/toxic, narcotic and precious crude drugs should be specially packaged, and appropriately marked.
Article 38 The crude drugs should not be put together with poisonous/toxic, hazardous and volatile materials during their transportation. Containers should be well-aerated to keep the crude drugs dry, and moisture proof measures should be in place.
Article 39 The warehouse for crude drugs should be airy and dry, and it should protect the crude drugs from direct sunlight. If necessary, air conditioners and dehumidifiers should be installed. Measures to prevent entry into the warehouse from insects, rodents, poultry and livestock should be taken. Floors should be neat and tidy, free from cracks and easy to clean.
The crude drugs should be placed on shelves and kept at an adequate distance from the wall, and avoid moth-eating, mould growth, rotting and oil spillage. Regular check should be conducted.
Modern technology and equipment for storage should be considered while traditional methods are applied.
Chapter VII Quality Management
Article 40 The producer should establish a quality management department which is responsible for supervision and quality control for the entire production process, and should have adequate staff, premises, instruments and equipment to meet the requirements of the scale of production and species identification.
Article 41 The quality management department has the following main responsibilities:
1.to monitor the environment and hygienic management;
2.to test production materials, packaging materials and the crude drugs, and to issue testing reports;
3.to develop training plans and supervise their implementation;
4.to formulate and manage quality documents, and to manage the original records of production, packaging, testing, etc.
Article 42 Prior to packaging, the quality control department should test each batch of the crude drugs in accordance with the national or approved standards for Chinese crude drugs. The testing items should at least include macroscopic characters and identification, impurities, moisture, ash and acid insoluble ash, extracts, and assay for marker or active constituents. Pesticide residue, heavy metals and microbiological limits should comply with the national standards and the relevant requirements.
Article 43 The testing reports should be signed by the operator and the responsible person of the quality control department, and then filed.
Article 44 The rejected Chinese crude drugs should not be released and marketed.
Chapter VIII Personnel and Facilities
Article 45 The responsible person for technology of a producer should possess qualifications of college education or above in pharmacy, agronomy, animal husbandry or the relevant specialties, and have experience in the production of crude drugs.
Article 46 The responsible person of the quality management department should possess qualifications of college education or above, and have experience in quality management of crude drugs.
Article 47 The personnel engaged in the production of crud e drugs should have basic knowledge of traditional Chinese pharmacy, agronomy or animal husbandry, and should receive training on production techniques, safety, and hygiene. Staff engaged in the field work should be familiar with cultivation techniques, especially the use of pesticides and safety protection; those engaged in rearing should be familiar with rearing techniques.
Article 48 The personnel engaged in processing, packaging or testing should undergo health examinations regularly and those suffering from infectious diseases, dermatitis or open wounds shall not be allowed to conduct work which is in direc t contact with crude drugs. The producer should designate a person to be responsible for checking sanitation and hygiene.
Article 49 The personnel engaged in the production of Chinese crude drugs are required to participate in regular training and examination.
Article 50 Toilets or washrooms should be set up in the production site of Chinese crude drugs. Excrement should not contaminate the environment or products.
Article 51 The applicable range and precision of instruments, meters, measures, weighers and balances, etc. used in production and testing, should conform to the elevant requirements, their performance status should be clearly indicated, and calibration should be conducted regularly.
Chapter IX Documentation
Article 52 The producer should formulate its standard operating procedures for production and quality management.
Article 53 Detailed records for the entire production process of each crude drug should be documented, and if necessary, photos or images might be attached, which should include:
1.origin of seeds, strains and propagation materials;
2.production techniques and process;
a.Seeding time, quantity and area of medicinal plants; seedling, transplantation, and the type, application schedule, quantity and usage of fertilizer; sort, quantity, application schedule and usage of pesticide, micro-biocide or herbicide;
b.Rearing daily record, turnover plan, breeding records, spawning records, medical records, death reports, death registration, records for quarantine and vaccination, feed formulae, feed consumption records, pedigree records and offspring identification of medicinal animals;
c.Collection time and yield, fresh weight and processing, drying and drying loss, transport and storage of medicinal parts;
d.Meteorological information, microclimate records;
e.Quality evaluations of crude drugs: description of macroscopic characters of crude drugs and records of test results.
Article 54 All the original records, production plans and their execution details, contracts or agreements etc. should be filed and kept properly for at least five years. The documents should be kept by a designated person.
Chapter X Supplementary Provisions
Article 55 Terms used in this GAP are defined as follows:
1)Chinese crude drugs refer to the raw medicinal materials from the medicinal parts of plants or animals, which are collected and primarily processed.
2)Producers of Chinesecrude drugs refer to units with certain scale, which conduct the cultivation of medicinal plants, or rearing of medicinal animals, primary processing, packaging and storage according to relevant procedure.
3)Maximum sustainable yield refers to the maximum yield of sustainable production (collection), without detriment to the ecological environment;
4)Geo-authentic (Di Dao) crude drugs refer to those of traditional Chinese crude drugs with specific germ plasma, production sites, or with specific production techniques and processing methods;
5)Seeds, strains and propagation materials refer to reproduction organs, tissues, cells, etc. of plants (fungi), and mycelia, sporocarp, etc. of fungi; a nd stud stock, breeds, eggs, etc. of animals.
6)Integrated pest management means to minimize the damage of pests and diseases under economic threshold as to improve economic and ecological interests, by biological, agricultural, chemical and/or other effective ecological means, considering local conditions. It should be prevention-oriented and based on the principle of safety, efficacy, economy and simplicity and convenience, and should integrate biological and environmental viewpoints.
7)Semi-wild medicinal animals/plants refer to wild animals/plants or those derived from cultivation with proper management, and intertilling, weeding, fertilizing or feeding, etc.
Article 56 The State Drug Administration is responsible for the interpretation of this GAP.
Article 57 This GAP shall come into force as of 1st June 2002.